The Recall Desk

Archive

October 2017 recalls

337 recalls were announced in October 2017.

What the numbers show

Critical
11
Severe
96
High
159
Moderate
58
Low
13

Of the 337 recalls this month scored against our rubric, 3% are Critical, 28% are Severe.

201–300 of 337

  • HighUSDA FSIS·107-2017·2017-10-05

    Publix Homestyle Beef Pot Roast Recalled for Undeclared Wheat and Soybean Oil

    Sandridge RMH Acquisition, LLC is recalling 1,222 pounds of Publix homestyle beef pot roast because the product is mislabeled and contains undeclared wheat and soybean oil.

    Product
    Sandridge RMH Acquisition, LLC Recalls Ready-To-Eat Beef Products Due To Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    2 states
  • HighNHTSA·17V621000·2017-10-05

    GM Recalls 2015-2016 Vehicles for Driver Air Bag Defect

    General Motors is recalling 2015-2016 Chevrolet Colorado, GMC Canyon, and 2016 Chevrolet Volt vehicles because the driver's frontal air bag may inflate improperly during a high-speed crash.

    Product
    CHEVROLET — CHEVROLET, GMC VOLT, COLORADO, CANYON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-3607-2017·2017-10-04

    Country Fresh Fajita Mix Recalled for Listeria Contamination Risk

    Country Fresh Products is recalling 6-oz Fajita Mix packages due to potential Listeria monocytogenes contamination. The product was distributed in five southern states.

    Product
    Fajita Mix, 6-oz. packaged in a clamshell
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-3580-2017·2017-10-04

    Country Fresh Stir Fry Vegetable Recalled for Listeria Risk

    Country Fresh Products is recalling 10-oz. Stir Fry Vegetable packages due to potential Listeria monocytogenes contamination.

    Product
    Stir Fry Vegetable, 10-oz. packaged in an overwrap
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-3361-2017·2017-10-04

    House Of Thaller Artisan Hummus Recalled for Listeria Risk

    House Of Thaller Inc is recalling Artisan Hummus Pine Nuts due to potential Listeria monocytogenes contamination.

    Product
    FRESH FOODS MARKET Artisan Humus Pine Nuts NET WT 10 oz (283g)
    Category
    Food
    Distribution
    32 states
  • CriticalFDA (Food)·F-3362-2017·2017-10-04

    Lantana White Bean Hummus Recalled for Listeria Risk

    House Of Thaller Inc is recalling Lantana White Bean Hummus because pine nuts may be contaminated with Listeria monocytogenes.

    Product
    LANTANA White Bean HUMMUS NET WT. 10 oz (283g)
    Category
    Food
    Distribution
    32 states
  • CriticalFDA (Food)·F-3605-2017·2017-10-04

    Country Fresh Products Recalls Creole Mix Due to Listeria Risk

    Country Fresh Products is recalling 6-oz. packages of Creole Mix due to potential contamination with Listeria monocytogenes.

    Product
    Creole Mix, 6-oz. packaged in a clamshell
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-3579-2017·2017-10-04

    Country Fresh Fajita Blend Recalled for Listeria Risk

    Country Fresh Products is recalling 12-oz Fajita Blend packages due to potential Listeria monocytogenes contamination. The product was distributed in five southeastern states.

    Product
    Fajita Blend, 12-oz. packaged in an overwrap
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-3585-2017·2017-10-04

    Marketside Classic Hummus with Pine Nuts Recalled for Listeria Risk

    House Of Thaller Inc is recalling Marketside Classic Hummus with Pine Nuts because the pine nuts may be contaminated with Listeria monocytogenes.

    Product
    Marketside CLASSIC HUMMUS WITH PINE NUTS NET WT. 10 oz (283g)
    Category
    Food
    Distribution
    32 states
  • SevereFDA (Devices)·Z-3187-2017·2017-10-04

    Zimmer Biomet Recalls ECT Quick-Connect Drills Due to Fracture Risk

    Zimmer Biomet is recalling 62 ECT Internal Fracture Fixation Quick-Connect Drills because raw material anomalies may cause the instruments to fracture during use.

    Product
    ECT Internal Fracture Fixation Quick-Connect Drill 3.5 mm Diameter 11 cm Length, Item Number/EDI 00241003500, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V620000·2017-10-04

    Grand Design Recalls 2017-2018 Imagine Trailers for Fire Risk

    Grand Design RV is recalling 2017-2018 Imagine recreational trailers because air conditioning wires may detach and short circuit, increasing fire risk.

    Product
    GRAND DESIGN — GRAND DESIGN IMAGINE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V617000·2017-10-04

    Hyundai Sonata Seat Belt Linkage Recall for Detachment Risk

    Hyundai is recalling 2011-2015 Sonata and Sonata Hybrid vehicles previously repaired under a prior campaign because seat belt linkages may detach from pretensioners, increasing injury risk in a crash.

    Product
    HYUNDAI — HYUNDAI SONATA HYBRID, SONATA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V618000·2017-10-04

    Prevost Recalls Motor Coaches Due to Fuel Tank Cradle Defect

    Prevost is recalling 2008-2018 motor coaches because fuel tank cradles may loosen, causing the tank to fall off and increasing crash risk.

    Product
    PREVOST — PREVOST X3-45 VIP ENTERTAINER, X3-45 VIP, XL2, H3-45 VIP
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3150-2017·2017-10-04

    Zimmer Biomet Recalls ECT Internal Fracture Fixation Quick-Connect Drills

    Zimmer Biomet is recalling 4 units of ECT Internal Fracture Fixation Quick-Connect Drills due to raw material anomalies that may increase the risk of instrument fracture.

    Product
    ECT Internal Fracture Fixation Quick-Connect Drill, 1.5 mm Diameter, 85mm Length, Item Number/EDI 00241001500, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3106-2017·2017-10-04

    Spectranetics Bridge Occlusion Balloon Catheter Recalled for Guidewire Issues

    Spectranetics is recalling Bridge Occlusion Balloon catheters because the guidewire may not pass through the device, potentially delaying treatment.

    Product
    Spectranetics Bridge Occlusion Balloon catheter, Sheath Compatibility 12F, Guidewire Compatibility 0.035in, Working Length 90cm, Balloon Outer Diameter 31mm, Balloon Length 80mm, Rx Only. Product Usage: It is a device used to occlude the vessel and prevent blood loss as the p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3228-2017·2017-10-04

    Sorin Platinium VR ICDs Recalled for Potential Overconsumption Risk

    Sorin Group is recalling Platinium VR implantable cardioverter defibrillators due to a possibility of overconsumption following electrostatic discharge or MRI scans.

    Product
    Platinium VR 1210, Model Number TDF031U, UDI/GTIN 08031527015514, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single chamber arrhythmia detection Product Usage: PLATINIUM VR is indicated for use in patients who are
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3202-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk

    Zimmer Biomet is recalling 150 nonsterile orthopedic drill bits because raw material anomalies may cause the instruments to fracture during use.

    Product
    Drill Bit Quick-Connect 4.5 mm Diameter 145 mm Length, Item Number/EDI 00480614545, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3178-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Screw Taps Due to Material Anomaly

    Zimmer Biomet is recalling 198 nonsterile orthopedic screw taps because raw material anomalies may increase the risk of instrument fracture during use.

    Product
    Zimmer Periarticular Locking Plate System, Locking Screw Tap Standard Quick-Connect 3.5 mm Diameter, Item Number/EDI 00236015335, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3167-2017·2017-10-04

    Zimmer Biomet Recalls ECT Internal Fixation Drill Bits Due to Fracture Risk

    Zimmer Biomet is recalling ECT Internal Fixation Drill Bits because raw material anomalies may cause the instruments to fracture during use.

    Product
    ECT Internal Fixation Drill Bits 2.5 mm Diameter (0.98 Inch), Item Number/EDI 00231802506, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3157-2017·2017-10-04

    Zimmer Biomet Recalls NCB Periprosthetic Plate System Drill Bits

    Zimmer Biomet is recalling 185 NCB Periprosthetic Plate System Drill Bits due to a raw material anomaly that may increase the risk of instrument fracture during use.

    Product
    NCB Periprosthetic Plate System Drill Bit With Quick-Coupling 4.5 mm Diameter 195 mm Length, Item Number/EDI 0200024330, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3188-2017·2017-10-04

    Zimmer Biomet Recalls ECT Internal Fracture Fixation Quick-Connect Drill Bits

    Zimmer Biomet is recalling 10 units of ECT Internal Fracture Fixation Quick-Connect Drills due to a raw material anomaly that may increase the risk of instrument fracture during use.

    Product
    ECT Internal Fracture Fixation Quick-Connect Drill 4.0 mm Diameter 20cm Length, Item Number/EDI 00241004000, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3199-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk

    Zimmer Biomet is recalling 15 nonsterile orthopedic drill bits because raw material anomalies may increase the risk of instrument fracture during use.

    Product
    Drill Bit Quick-Connect 3-Fluted 4.5 mm Diameter 195 mm Length, Item Number/EDI 00480719545, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·106-2017·2017-10-04

    Thompson's Ground Beef Recalled for Possible E. coli O157:H7 Contamination

    Clair D. Thompson & Sons, Inc. is recalling approximately 700 pounds of ground beef products due to possible E. coli O157:H7 contamination.

    Product
    Clair D. Thompson & Sons, Inc. Recalls Ground Beef Products Due To Possible E. Coli O157:H7 Contamination
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-3193-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk

    Zimmer Biomet is recalling specific orthopedic drill bits and screw taps because a raw material anomaly may increase the risk of instrument fracture during use.

    Product
    Drill Bit Quick-Connect 2.0 mm Diameter 100 mm Length, Item Number/EDI 00480610020, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3158-2017·2017-10-04

    Zimmer Biomet Recalls M/DN Intramedullary Fixation Distal Drill Pilot Tips

    Zimmer Biomet is recalling 182 M/DN Intramedullary Fixation Distal Drill Pilot Tips due to raw material anomalies that may increase the risk of instrument fracture.

    Product
    M/DN Intramedullary Fixation Distal Drill Pilot Tip 3.2 mm Diameter, Item Number/EDI 00225503332, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3175-2017·2017-10-04

    Zimmer Biomet Recalls Straight Shank Drill Bits Due to Fracture Risk

    Zimmer Biomet is recalling 62 units of 4.0 mm Straight Shank Drill Bits because raw material anomalies may increase the risk of instrument fracture during use.

    Product
    Straight Shank Drill Bits 4.0 mm Diameter, Item Number/EDI 00231804006, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3191-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk

    Zimmer Biomet is recalling specific orthopedic drill bits and screw taps because raw material anomalies may cause the instruments to fracture during use.

    Product
    Drill Bit Jacobs Chuck 3.2 mm Diameter 130 mm Length, Item Number/EDI 00480513032, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V619000·2017-10-04

    Lexus Recalls 2010 HS 250h Hybrid for Transaxle Short Circuit Risk

    Toyota is recalling 2010 Lexus HS 250h Hybrid vehicles because a hybrid transaxle component may short circuit, causing a loss of power and increasing crash risk.

    Product
    LEXUS — LEXUS HS 250 HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3183-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk

    Zimmer Biomet is recalling specific orthopedic drill bits and screw taps because raw material anomalies may cause the instruments to fracture during use.

    Product
    ECT Internal Fracture Fixation Quick-Connect Drill 2.0 mm Diameter 12.5 cm Length, Item Number/EDI 00241002100, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3151-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Surgical Drill Bits and Screw Taps

    Zimmer Biomet is recalling specific orthopedic surgical instruments due to a raw material anomaly that may increase the risk of instrument fracture during use.

    Product
    Zimmer Natural Nail System Calibrated Drill Long 4.3mm, Item Number/EDI 00249004443, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3180-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Surgical Drills Due to Fracture Risk

    Zimmer Biomet is recalling 1,091 nonsterile orthopedic surgical drills and screw taps because raw material anomalies may cause instrument fracture.

    Product
    Zimmer Periarticular Locking Plate System Drill Standard 2.0 mm Diameter, Item Number/EDI 00236017520, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3231-2017·2017-10-04

    Sorin Platinium VR ICDs Recalled for Potential Overconsumption Risk

    Sorin Group is recalling 72 Platinium VR implantable cardioverter defibrillators due to a possibility of overconsumption following electrostatic discharge or MRI scans.

    Product
    Platinium VR DF4 1240, Model Number TDF035U, UDI/GTIN 08031527015460, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single chamber arrhythmia detection Product Usage: PLATINIUM VR is indicated for use in patients who
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1177-2017·2017-10-04

    Pfizer Recalls Sterile Water for Injection Vials Due to Cracked Glass

    Pfizer is recalling 18,725 vials of Sterile Water for Injection due to cracked or chipped glass at the neck, which poses a non-sterility risk.

    Product
    Sterile Water for Injection, USP Single Dose 100 mL vials, Rx only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 USA for Genentech, Inc., South San Francisco, CA 94080-4990. NDC 50242-901-24
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3160-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Surgical Instruments Due to Fracture Risk

    Zimmer Biomet is recalling 21 units of M/DN Intramedullary Fixation Femoral Drills because raw material anomalies may cause the instruments to fracture during use.

    Product
    M/DN Intramedullary Fixation Femoral Drill Large 5.0 mm Item Number/EDI 00225503550, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3181-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Surgical Drills and Screw Taps

    Zimmer Biomet is recalling 1,129 orthopedic surgical drills and screw taps due to raw material anomalies that may increase the risk of instrument fracture.

    Product
    Zimmer Periarticular Locking Plate System Drill Standard 2.7 mm Diameter, Item Number/EDI 00236020527, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3196-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk

    Zimmer Biomet is recalling specific orthopedic drill bits and screw taps because raw material anomalies may increase the risk of instrument fracture during use.

    Product
    Drill Bit Quick-Connect 3.5 mm Diameter 110 mm Length, Item Number/EDI 00480611035, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3164-2017·2017-10-04

    Zimmer Biomet Recalls ECT Internal Fracture Fixation Drills

    Zimmer Biomet is recalling 4,423 ECT Internal Fracture Fixation Drills because raw material anomalies may increase the risk of instrument fracture during use.

    Product
    ECT Internal Fracture Fixation Drill 2.0 mm Diameter (.079 Inch), Item Number/EDI 00231802000, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-3575-2017·2017-10-04

    Wegmans Dark Chocolate Cherry Cashew Granola Bars Recalled for Vitamin A

    Treehouse Foods is recalling Wegmans Dark Chocolate Cherry Cashew chewy granola bars because they may contain a higher concentration of Vitamin A than declared on the label.

    Product
    Wegmans Dark Chocolate Cherry Cashew chewy granola bars, 12-1.4OZ(40g) bars, Total Net Wt. 16.8OZ (1 LB 0.8OZ) 480g, UPC 77890-42230
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-3604-2017·2017-10-04

    Country Fresh Diced Green Pepper Recalled for Listeria Risk

    Country Fresh Products is recalling diced green peppers due to potential Listeria monocytogenes contamination. The product was distributed in five southeastern states.

    Product
    Green Pepper Diced, 6-oz. packaged in a clamshell
    Category
    Food
    Distribution
    5 states
  • HighCPSC·18002·2017-10-04

    SRAM Recalls Avid SD7 Bicycle Brakes Due to Crash and Injury Hazards

    SRAM is recalling Avid SD7 bicycle brakes because a rivet can loosen, causing brake failure. Consumers should stop using them and contact SRAM for a free replacement.

    Product
    Bicycle brakes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-3581-2017·2017-10-04

    Country Fresh Vegetable Kabob Recall for Listeria Contamination

    Country Fresh Products is recalling specific vegetable kabob products due to potential contamination with Listeria monocytogenes.

    Product
    Vegetable Kabob, 23-oz. packaged in an overwrap; Kabob Sensations Veggie Kabob, 15-oz. packaged in am overwrap; Marketside Veggie Kabobs, 23-oz. packaged in an overwrap
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-3606-2017·2017-10-04

    Country Fresh Tri-Pepper Dice Recalled for Listeria Contamination Risk

    Country Fresh Products is recalling Tri-Pepper Dice due to potential Listeria monocytogenes contamination. Consumers in five states should discard the product.

    Product
    Tri-Pepper Dice, 6-oz. packaged in a clamshell and Dice Tri-Pepper, 7-oz. packaged in a clamshell
    Category
    Food
    Distribution
    5 states
  • HighNHTSA·17V624000·2017-10-04

    Transtech Recalls 2015-2016 School Buses Due to Seat Padding Defect

    Transportation Collaborative is recalling 2015-2016 Trans Tech school buses because seat mounting studs lack adequate padding, increasing injury risk in rear-end collisions.

    Product
    TRANS TECH BUS — TRANS TECH BUS ST AERO, SST FLR, STUDENT SAFETY TRANSPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3145-2017·2017-10-04

    Zimmer Biomet Recalls Herbert Cannulated Bone Screw System Drills

    Zimmer Biomet is recalling 18 units of Herbert Cannulated Bone Screw System drills due to raw material anomalies that may increase the risk of instrument fracture.

    Product
    Herbert Cannulated Bone Screw System, Cannulated Main Drill 3.1 mm Diameter, Item Number/EDI 00115501500, Nonsterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3192-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk

    Zimmer Biomet is recalling 705 nonsterile orthopedic drill bits and screw taps because raw material anomalies may cause instrument fracture during use.

    Product
    Drill Bit Quick-Connect 1.5 mm Diameter 85 mm Length, Item Number/EDI 00480608515, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3203-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk

    Zimmer Biomet is recalling 75 nonsterile orthopedic drill bits because raw material anomalies may increase the risk of instrument fracture during use.

    Product
    Drill Bit Quick-Connect 3.2 mm Diameter 195 mm Length, Item Number/EDI 00480619532, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3182-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk

    Zimmer Biomet is recalling 418 ECT Internal Fracture Fixation Quick-Connect Drills because raw material anomalies may increase the risk of instrument fracture during use.

    Product
    ECT Internal Fracture Fixation Quick-Connect Drill 2.0 mm Diameter 10 cm Length, Item Number/EDI 00241002000, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3229-2017·2017-10-04

    Sorin Platinium ICDs Recalled for Potential Overconsumption Risk

    Sorin Group Italia SRL is recalling Platinium DR 1510 ICDs due to a possibility of overconsumption following ElectroStatic Discharge (ESD) during implant surgery or MRI scans.

    Product
    Platinium DR 1510, Model Number TDF032U, UDI/GTIN 08031527015521, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single chamber arrhythmia detection Product Usage: PLATINIUM VR is indicated for use in patients who are
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3197-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Drill Bits Due to Material Anomaly

    Zimmer Biomet is recalling 236 nonsterile orthopedic drill bits because raw material anomalies may increase the risk of instrument fracture during use.

    Product
    Drill Bit Quick-Connect 3.2 mm Diameter 145 mm Length, Item Number/EDI 00480614532, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3152-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk

    Zimmer Biomet is recalling 155 orthopedic drill bits and screw taps because raw material anomalies may cause the instruments to fracture during use.

    Product
    Drill Bit Jacobs Chuck 1.5 mm Diameter 70 mm Length, Item Number/EDI 00480507015, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3201-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Surgical Drills Due to Fracture Risk

    Zimmer Biomet is recalling specific orthopedic surgical drills and screw taps because raw material anomalies may cause the instruments to fracture during use.

    Product
    Zimmer Natural Nail System Freehand Drill 4.3 mm Diameter 152.5 mm Length, Item Number/EDI 00249007543, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3224-2017·2017-10-04

    Teleflex Percuvance Surgical System Recalled for Connection and Tip Defects

    Teleflex Medical is recalling Percuvance 29cm Shaft surgical systems because the shaft connection may be compromised or tool tips may close abruptly.

    Product
    Percuvance 29cm Shaft The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver Hem-o-lok ligating clips to soft tissue du
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-3198-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk

    Zimmer Biomet is recalling specific orthopedic drill bits and screw taps because raw material anomalies may cause instrument fracture during use.

    Product
    Drill bit Quick-Connect 3-Fluted 2.5 mm Diameter 180 mm Length, Item Number/EDI 00480718025, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3220-2017·2017-10-04

    Teleflex Recalls Percuvance Clip Applier Tool Tips Due to Connection Issues

    Teleflex Medical is recalling 20,039 Percuvance Clip Applier Tool Tips because the shaft connection may be compromised or the jaws may close abruptly.

    Product
    Percuvance Clip Applier Tool Tip The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver Hem-o-lok ligating clips to sof
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-3147-2017·2017-10-04

    Zimmer Biomet Recalls M/DN Intramedullary Fixation Femoral Drill Bits

    Zimmer Biomet is recalling 25 units of M/DN Intramedullary Fixation Femoral Drills due to raw material anomalies that may increase the risk of instrument fracture during use.

    Product
    M/DN Intramedullary Fixation Femoral Drill 3.7 mm Diameter Replaces 2255-08-32, Item Number/EDI 00225503137, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3195-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk

    Zimmer Biomet is recalling specific nonsterile orthopedic drill bits because raw material anomalies may increase the risk of instrument fracture during use.

    Product
    Drill Bit Quick-Connect 2.5 mm Diameter 110 mm Length, Item Number/EDI 00480611025, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3221-2017·2017-10-04

    Teleflex Percuvance Johans Grasper Tool Tip Recall for Connection and Jaw Issues

    Teleflex Medical is recalling Percuvance Johans Grasper Tool Tips because the shaft connection may be compromised or the jaws may close abruptly.

    Product
    Percuvance Johans Grasper Tool Tip The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver Hem-o-lok ligating clips to s
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-3153-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk

    Zimmer Biomet is recalling 25 nonsterile orthopedic drill bits because raw material anomalies may increase the risk of instrument fracture during use.

    Product
    Drill Bit Quick-Connect 1.1 mm Diameter 60 mm Length, Item Number/EDI 00480606011, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3173-2017·2017-10-04

    Zimmer Biomet Recalls ECT Internal Fracture Fixation Drill Bits

    Zimmer Biomet is recalling 389 ECT Internal Fracture Fixation Drill Bits due to raw material anomalies that may increase the risk of instrument fracture during use.

    Product
    ECT Internal Fracture Fixation Drill Bits 3.5 mm Diameter (.138 Inch), Item Number/EDI 00231803506, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3235-2017·2017-10-04

    Novadaq SPY-PHI PAQ Sterile Drape Recall Due to Pinholes

    Novadaq is recalling SPY-PHI PAQ kits because pinholes in the sterile drape may compromise the sterile barrier. The product is used in medical procedures.

    Product
    NOVADAQ SPY-PHI PAQ Intended for use with the SPY-PHI System, Product Code HH9006, containing 6 Single-Procedure Kits (Product Code HH9001), each containing the sterile drape (HH2000), as well as single-use drug components, Manufactured for and Distributed by Novadaq Technologies
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3154-2017·2017-10-04

    Zimmer Biomet Recalls NCB Periprosthetic Plate System Drill Bits

    Zimmer Biomet is recalling 300 nonsterile NCB Periprosthetic Plate System Drill Bits due to raw material anomalies that may increase the risk of instrument fracture during use.

    Product
    NCB Periprosthetic Plate System Drill Bit With Quick-Coupling 3.5 mm Diameter 195 mm Length, Item Number/EDI 0200024325, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3222-2017·2017-10-04

    Teleflex Percuvance Maryland Dissector Tool Tip Recall for Connection Issues

    Teleflex Medical is recalling Percuvance Maryland Dissector Tool Tips because the shaft connection may be compromised or the jaws may close abruptly.

    Product
    Percuvance Maryland Dissector Tool Tip The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver Hem-o-lok ligating clips
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-3184-2017·2017-10-04

    Zimmer Biomet Recalls ECT Internal Fracture Fixation Quick-Connect Drills

    Zimmer Biomet is recalling 412 ECT Internal Fracture Fixation Quick-Connect Drills because raw material anomalies may increase the risk of instrument fracture during use.

    Product
    ECT Internal Fracture Fixation Quick-Connect Drill 2.5 mm Diameter 11 cm Length, Item Number/EDI 00241002500, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3156-2017·2017-10-04

    Zimmer Biomet Recalls ECT Internal Fracture Fixation Long Drills

    Zimmer Biomet is recalling 10 units of ECT Internal Fracture Fixation Long Drills due to raw material anomalies that may increase the risk of instrument fracture.

    Product
    ECT Internal Fracture Fixation Long Drill, 6.4 mm (1/4 Inch) Diameter 20.3 cm(8 Inch) Length, Item Number/EDI 00129100406, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3234-2017·2017-10-04

    Novadaq SPY-PHI Drape Recalled for Potential Sterile Barrier Breach

    Novadaq is recalling SPY-PHI Drapes because pinholes may compromise the sterile barrier. The product is intended for equipment coverage, not patient contact.

    Product
    NOVADAQ SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref. HH2000 (single drape), Sterile, Rx. Manufactured for: Novadaq Technologies Inc., Burnaby, BC, Canada. The SPY-PHI Drape is intended to cover the SPY-PHI System to maintain a sterile field, and as an aid in the clean-up
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3185-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk

    Zimmer Biomet is recalling 198 ECT Internal Fracture Fixation Quick-Connect Drills because raw material anomalies may cause the instruments to fracture during use.

    Product
    ECT Internal Fracture Fixation Quick-Connect Drill 2.5 mm Diameter 12.5 cm Length, Item Number/EDI 00241002600, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3219-2017·2017-10-04

    Teleflex Percuvance Gripper Grasper Tool Tip Recall for Connection Issues

    Teleflex Medical is recalling 20,039 Percuvance Gripper Grasper Tool Tips because the shaft connection may be compromised or the jaws may close abruptly.

    Product
    Percuvance Gripper Grasper Tool Tip The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver Hem-o-lok ligating clips to
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-3174-2017·2017-10-04

    Zimmer Biomet Recalls Straight Shank Drill Bits Due to Fracture Risk

    Zimmer Biomet is recalling 173 nonsterile straight shank drill bits because raw material anomalies may increase the risk of instrument fracture during use.

    Product
    Straight Shank Drill Bit 4.0 mm Diameter, Item Number/EDI 00231804000, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3168-2017·2017-10-04

    Zimmer Biomet Recalls ECT Internal Fracture Fixation Drills Due to Material Anomaly

    Zimmer Biomet is recalling 1,250 ECT Internal Fracture Fixation Drills because raw material anomalies may increase the risk of instrument fracture during use.

    Product
    ECT Internal Fracture Fixation Drill 2.7 mm Diameter (.106 Inch), Item Number/EDI 00231802700, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3163-2017·2017-10-04

    Zimmer Biomet Recalls ECT Internal Fracture Fixation Drill Bits

    Zimmer Biomet is recalling 1,558 ECT Internal Fracture Fixation Drill Bits because raw material anomalies may increase the risk of instrument fracture during use.

    Product
    ECT Internal Fracture Fixation Drill Bits 1.5 mm Diameter (.059 Inch), Item Number/EDI 00231801506, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3171-2017·2017-10-04

    Zimmer Biomet Recalls ECT Internal Fracture Fixation Drill Bits

    Zimmer Biomet is recalling 2,038 ECT Internal Fracture Fixation Drill Bits due to raw material anomalies that may increase the risk of instrument fracture.

    Product
    ECT Internal Fracture Fixation Drill Bits 3.2 mm Diameter (.126 Inch), Item Number/EDI 00231803206, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3169-2017·2017-10-04

    Zimmer Biomet Recalls ECT Internal Fracture Fixation Drill Bits

    Zimmer Biomet is recalling 1,286 ECT Internal Fracture Fixation Drill Bits due to raw material anomalies that may increase the risk of instrument fracture during use.

    Product
    ECT Internal Fracture Fixation Drill Bits 2.7 mm Diameter (.106 Inch), Item Number/EDI 00231802706, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-3574-2017·2017-10-04

    Rajbhog Jalebi Recalled for Undeclared Almond Allergen

    Rajbhog Distributors is recalling 1,467 packets of Jalebi sweet due to an undeclared almond allergen. The product was distributed in seven southeastern states.

    Product
    Rajbhog Sweet, JALEBI, Net Weight 11.2 oz. (315 grams), Distributed by Rajbhog Distributors (GA) Inc., Duluth, GA 30096.
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-3186-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk

    Zimmer Biomet is recalling 240 ECT Internal Fracture Fixation Quick-Connect Drills because raw material anomalies may cause the instruments to fracture during use.

    Product
    ECT Internal Fracture Fixation Quick-Connect Drill 2.7 mm Diameter 10 cm Length, Item Number/EDI 00241002700, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3236-2017·2017-10-04

    Novadaq SPY-PHI Drape Recall Due to Potential Sterile Barrier Breach

    Novadaq is recalling SPY-PHI Drapes because pinholes may compromise the sterile barrier. The product is used to cover surgical equipment, not patients.

    Product
    NOVADAQ SPY-PHI Drape, 7" x 104" (18 cm x 265 cm), Ref. HH 2020 (box of 20 HH2000 drapes), Sterile, Rx.. Manufactured for: Novadaq Technologies Inc., Burnaby, BC, Canada. The SPY-PHI Drape is intended to cover the SPY-PHI System to maintain a sterile field, and as an aid in th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3225-2017·2017-10-04

    Fujifilm Recalls 362 Fujinon ED-530XT Endoscopes for Reprocessing Risk

    Fujifilm Medical Systems is recalling 362 Fujinon ED-530XT endoscopes nationwide to reduce patient risk from inadequate reprocessing.

    Product
    FUJINON ED-530XT. This device is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3149-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Surgical Instruments Due to Fracture Risk

    Zimmer Biomet is recalling 171 orthopedic surgical instruments because raw material anomalies may increase the risk of instrument fracture during use.

    Product
    Zimmer Periarticular Locking Plate System Locking Screw Tap Standard Quick-Connect, 2.7 mm Diameter, Item Number/EDI 00236015327, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3233-2017·2017-10-04

    Sorin Platinium CRT-D Recall for Potential Overconsumption After ESD or MRI

    Sorin Group is recalling 68 Platinium CRT-D devices due to a possibility of overconsumption of the device following electrostatic discharge or an MRI scan.

    Product
    Platinium CRT-D 1741, Model Number TDF037U, UDI/GTIN 08031527015484, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single chamber arrhythmia detection Product Usage: PLATINIUM VR is indicated for use in patients who
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3200-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk

    Zimmer Biomet is recalling 453 nonsterile orthopedic drill bits because raw material anomalies may cause instrument fracture during use.

    Product
    Drill Bit Quick-Connect Calibrated 3-Fluted 2.5 mm Diameter 230 mm Length, Item Number/EDI 00480723025, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3190-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk

    Zimmer Biomet is recalling 30 units of orthopedic drill bits because raw material anomalies may cause the instruments to fracture during use.

    Product
    Drill Bit Jacobs Chuck 2.0 mm Diameter 85 mm Length, Item Number/EDI 00480508520, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3146-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Surgical Drills Due to Fracture Risk

    Zimmer Biomet is recalling 2 units of Long Drill 1/4 inch orthopedic surgical instruments due to raw material anomalies that may increase the risk of instrument fracture.

    Product
    Long Drill 1/4 inch (6.4 mm) Diameter 8 inch (20.3 cm) Length, Item Number/EDI 00129100400, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3165-2017·2017-10-04

    Zimmer Biomet Recalls ECT Internal Fracture Fixation Drill Bits

    Zimmer Biomet is recalling 3,640 ECT Internal Fracture Fixation Drill Bits because raw material anomalies may increase the risk of instrument fracture during use.

    Product
    ECT Internal Fracture Fixation Drill Bits 2.0 mm Diameter (.079 Inch) , Item Number/EDI 00231802006, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3159-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Drill Pilot Tips Due to Fracture Risk

    Zimmer Biomet is recalling 27 nonsterile orthopedic drill pilot tips because raw material anomalies may increase the risk of instrument fracture during use.

    Product
    M/DN, Intramedullary Fixation Distal Drill Pilot Tip 3.7 mm Diameter Item Number/EDI 00225503337, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3172-2017·2017-10-04

    Zimmer Biomet Recalls ECT Internal Fracture Fixation Drills Due to Material Anomaly

    Zimmer Biomet is recalling 356 ECT Internal Fracture Fixation Drills because a raw material anomaly may increase the risk of instrument fracture during use.

    Product
    ECT Internal Fracture Fixation Drill 3.5 mm Diameter (.138 Inch), Item Number/EDI 00231803500, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3179-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Surgical Instruments Due to Material Anomaly

    Zimmer Biomet is recalling 173 orthopedic surgical instruments because a material anomaly may increase the risk of instrument fracture during use.

    Product
    Zimmer Periarticular Locking Plate System Cannulated Drill Standard Quick-Connect 2.7 mm O.D., Item Number/EDI 00236017127, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3161-2017·2017-10-04

    Zimmer Biomet Recalls ECT Internal Fracture Fixation Drill Bits

    Zimmer Biomet is recalling 439 ECT Internal Fracture Fixation Drill Bits due to raw material anomalies that may increase the risk of instrument fracture during use.

    Product
    ECT Internal Fracture Fixation Drill Bits 1.1 mm Diameter, Item Number/EDI 00231801106, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3155-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk

    Zimmer Biomet is recalling 224 sterile M/DN Intramedullary Fixation Distal Drills because raw material anomalies may increase the risk of instrument fracture during use.

    Product
    M/DN Intramedullary Fixation Distal Drill 3.2 mm Diameter Pilot Tip, Item Number/EDI 47225503332, Sterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3144-2017·2017-10-04

    Zimmer Biomet Recalls Sterile Shoulder System Drills Due to Fracture Risk

    Zimmer Biomet is recalling 2,825 sterile shoulder system drills manufactured with raw material anomalies that may increase the risk of instrument fracture.

    Product
    Zimmer Trabecular Metal Reverse Shoulder System Instrumentation, Drill 2.5 mm Diameter, Item Number/EDI 47430904601, Sterile
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3170-2017·2017-10-04

    Zimmer Biomet Recalls ECT Internal Fracture Fixation Drill Bits

    Zimmer Biomet is recalling 1,255 ECT Internal Fracture Fixation Drill Bits due to raw material anomalies that may increase the risk of instrument fracture during use.

    Product
    ECT Internal Fracture Fixation Drill 3.2 mm Diameter (.126 Inch), Item Number/EDI 00231803200, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3194-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk

    Zimmer Biomet is recalling specific orthopedic drill bits and screw taps because raw material anomalies may increase the risk of instrument fracture during use.

    Product
    Drill Bit Quick-Connect 2.7 mm Diameter 100 mm Length, Item Number/EDI 00480610027, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3177-2017·2017-10-04

    Zimmer Biomet Recalls ECT Internal Fracture Fixation Drill Bits

    Zimmer Biomet is recalling 217 nonsterile ECT Internal Fracture Fixation Drill Bits due to a raw material anomaly that may increase the risk of instrument fracture.

    Product
    ECT Internal Fracture Fixation Drill Bits 4.5 mm Diameter (.177 Inch), Item Number/EDI 00231804506, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3166-2017·2017-10-04

    Zimmer Biomet Recalls ECT Internal Fracture Fixation Drills Due to Material Anomaly

    Zimmer Biomet is recalling 3,232 ECT Internal Fracture Fixation Drills because raw material anomalies may increase the risk of instrument fracture during use.

    Product
    ECT Internal Fracture Fixation Drill 2.5 mm Diameter (.098 Inch), Item Number/EDI 00231802500, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3176-2017·2017-10-04

    Zimmer Biomet Recalls ECT Internal Fracture Fixation Drill Bits

    Zimmer Biomet is recalling 381 ECT Internal Fracture Fixation Drill bits due to raw material anomalies that may increase the risk of instrument fracture during use.

    Product
    ECT Internal Fracture Fixation Drill 4.5 mm Diameter (.177 Inch), Item Number/EDI 00231804500, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3162-2017·2017-10-04

    Zimmer Biomet Recalls ECT Internal Fracture Fixation Drills Due to Material Anomaly

    Zimmer Biomet is recalling 1,999 ECT Internal Fracture Fixation Drills because raw material anomalies may increase the risk of instrument fracture during use.

    Product
    ECT Internal Fracture Fixation Drill 1.5 mm Diameter (.059 Inch), Item Number/EDI 00231801500, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3230-2017·2017-10-04

    Sorin Platinium ICDs Recalled for Potential Overconsumption Risk

    Sorin Group is recalling Platinium ICDs and CRT-Ds due to a possibility of overconsumption following electrostatic discharge or MRI scans.

    Product
    Platinium CRT DF1 1711, Model Number TDF033U, UDI/GTIN 08031527015538, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single chamber arrhythmia detection Product Usage: PLATINIUM VR is indicated for use in patients wh
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3232-2017·2017-10-04

    Sorin Platinium ICDs Recalled for Potential Overconsumption Risk

    Sorin Group is recalling Platinium ICDs and CRT-Ds due to a possibility of overconsumption following electrostatic discharge or MRI scans.

    Product
    Platinium DR DF4 1540, Model Number TDF036U, UDI/GTIN 08031527015477, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single chamber arrhythmia detection Product Usage: PLATINIUM VR is indicated for use in patients who
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·18003·2017-10-04

    Suunto Recalls Wireless Tank Transmitters Due to Bursting Hazard

    Suunto is recalling approximately 35,500 Wireless Tank Transmitters and Tank PODs because the exterior plastic case can burst during pre-dive pressure testing, posing an injury hazard.

    Product
    Wireless Tank Transmitter and Tank POD
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3148-2017·2017-10-04

    Zimmer Biomet Recalls ECT Internal Fracture Fixation Drills Due to Material Anomaly

    Zimmer Biomet is recalling 751 ECT Internal Fracture Fixation Drills because raw material anomalies may increase the risk of instrument fracture during use.

    Product
    ECT Internal Fracture Fixation Drill 1.1 mm Diameter (.043 Inch), Item Number/EDI 00231801100, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3189-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Surgical Drill Bits Due to Fracture Risk

    Zimmer Biomet is recalling 62 units of the Natural Nail System Calibrated Drill Short 4.9 mm because raw material anomalies may increase the risk of instrument fracture during use.

    Product
    Zimmer Natural Nail System Calibrated Drill Short 4.9 mm, Item Number/EDI 00249006449, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide

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